Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation

N/ANot Yet RecruitingNCT07842601

University of Kentucky60 enrolled

Overview

This study will compare transcranial magnetic stimulation (TMS) with sham TMS in people with opioid use disorder who are taking buprenorphine and have major depressive disorder with ongoing depressive symptoms. The study will evaluate whether TMS improves depressive symptoms and reduces opioid craving. The study will also assess smoking behaviors, treatment acceptability, and any side effects related to TMS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Opioid Use Disorder Major Depressive Disorder (MDD)

Interventions

Transcranial Magnetic Stimulation (TMS)DEVICE

Intermittent theta burst stimulation (iTBS) delivered over the left dorsolateral prefrontal cortex using a TMS coil.

Sham Transcranial Magnetic Stimulation (TMS)DEVICE

Sham Transcranial Magnetic Stimulation (TMS) delivered using the same procedure as active TMS without a significant electric field induced around the brain.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-75 years of age * Willing and able to provide informed consent * Able to read and speak english * Opioid use disorder, in remission for at least a month * Diagnosis of major depressive disorder confirmed with the Mini-International Neuropsychiatric Interview (MINI, 7.02) * Minimum score of 10 on the 17-item Hamilton Depression Rating Scale (HDRS-17) * Opioid craving score of 5 or greater on a 0-10 scale * Stabilized on sublingual or depot buprenorphine for at least 8 weeks Exclusion Criteria: * Seizure disorder * any other acute medical or behavioral disorder that would preclude safe participation * Pregnant, nursing or planning to become pregnant during the study * Magnetic resonance imaging (MRI) contraindications, including ferrous retainers, intracranial implants, or claustrophobia * Surgical procedure planned during the study period * Any other medical condition that could compromise participant well-being

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Change in Depressive Symptom Severity

Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline, comparing participants receiving transcranial magnetic stimulation (TMS) with those receiving Shame TMS. Higher scores indicate greater depressive symptom severity. The HDRS-17 ranges from 0-52.

Time frame: Baseline through Week 13

Change in Opioid Craving

Change in opioid craving as measured by the Opioid Craving Scale (OCS) from baseline, comparing participants receiving the TMS with those receiving sham TMS. The OCD consists of three items rated 0 to 10, with the total score calculated as the average of the three items. A higher score indicates greater opioid craving.

Time frame: Baseline through Week 13

Central Contacts

Gopalkumar Rakesh, MD

CONTACT

8592576402 Gopalkumar.Rakesh@uky.edu

Data from ClinicalTrials.gov

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